File downloaded on 2026-04-06
Source URL: https://medicines.health.europa.eu/veterinary/en/600000047677
Authorised

Product identification

Medicine name:
Phenoleptil 12.5 mg tablets for dogs
Active substance:
  • Phenobarbital
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenobarbital
    12.50
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN03AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 5 strips
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 10 strips
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 25 strips
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 50 strips
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 100 strips
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 100 strips
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 50 strips
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 25 strips
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 10 strips
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 5 strips

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401259.00.00
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0635/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 6/07/2025
Download
German (PDF)
Published on: 22/09/2025
Download